Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

Colorectal Cancer Clinical Trial

— X-PECT  

Official title:

A Phase III Randomized Study to Assess the Efficacy and Safety of Perifosine Plus Capecitabine Versus Placebo Plus Capecitabine in Patients With Refractory Advanced Colorectal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01097018
• Other study ID #: Protocol 343
• Status: Completed
• Phase: Phase 3
• First received: March 30, 2010
• Last updated: June 25, 2013
• Start date: April 2010
• Est. completion date: April 2012

Study information

• Verified date: June 2013
• Source: AEterna Zentaris
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The trial will compare the overall survival of perifosine plus capecitabine to placebo plus capecitabine in patients with refractory advanced colorectal cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients must have failed available therapy for the treatment of advanced colorectal cancer, including fluoropyrimidine, irinotecan, oxaliplatin, bevacizumab and for K-ras wild-type (WT) patients, anti-EGFR antibody (cetuximab or panitumumab) containing therapies.

• For oxaliplatin-based therapy, failure of therapy will also include patients who had oxaliplatin discontinued secondary to toxicity.

• No prior exposure to capecitabine in the metastatic colorectal cancer setting, except limited-course radiosensitizing capecitabine

• Patients must have at least one measurable lesion by RECIST criteria

Exclusion Criteria:

• Patients with known dipyrimidine dehydrogenase (DPD) deficiency or prior severe reaction to 5-FU

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Drug:
• Capecitabine
1000 mg/m2 BID/ Days 1-14
• Perifosine
50 mg daily x 21 days
• Placebo
1 pill daily x 21 days

Locations

Country	Name	City	State
United States	TN Oncology	Nashville	Tennessee
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
AEterna Zentaris

Country where clinical trial is conducted

United States, 

References & Publications (1)

Results of the X-PECT study: A phase III randomized double-blind, placebo-controlled study of perifosine plus capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with refractory metastatic colorectal cancer (mCRC). https://meetin

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival		Monthly	No
Secondary	Progression-free Survival		Every 6 weeks	No

External Links

•   Results